US2024245917A1PendingUtilityA1

Use of blood flow images to inform scs workflow

Assignee: BOSTON SCIENT NEUROMODULATION CORPPriority: Jan 24, 2023Filed: Jan 22, 2024Published: Jul 25, 2024
Est. expiryJan 24, 2043(~16.5 yrs left)· nominal 20-yr term from priority
G06T 2207/30104G06T 2207/10048G06T 7/0016A61N 1/36071A61N 1/37247A61N 1/36062A61N 1/36135G06T 2207/30012
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Claims

Abstract

A medical system may include a spinal cord stimulation (SCS) system, a thermographic imaging system, and an SCS suitability analyzer. The SCS system may be configured to deliver spinal cord neuromodulation including deliver a test SCS. The thermographic imaging system may be configured for taking thermal images of at least a portion of a patient. The SCS suitability analyzer may be configured to create thermographic imaging comparison data by comparing a thermographic imaging response to the test SCS to a thermographic imaging baseline before the test SCS is delivered, and analyze the thermographic imaging comparison data for an indicator of a significant perfusion response to the test SCS to determine whether the patient is a suitable candidate for SCS. A method may include capturing a thermographic imaging response to delivered SCS and performing, using the thermographic imaging response, a sweet spot determination for delivering the SCS.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A system, comprising:
 a spinal cord stimulation (SCS) system configured to deliver spinal cord neuromodulation including deliver a test SCS;   a thermographic imaging system configured for taking thermal images of at least a portion of a patient; and   an SCS suitability analyzer configured to:
 create thermographic imaging comparison data by comparing a thermographic imaging response to the test SCS to a thermographic imaging baseline before the test SCS is delivered; and 
 analyze the thermographic imaging comparison data for an indicator of a significant perfusion response to the test SCS to determine whether the patient is a suitable candidate for SCS. 
   
     
     
         2 . The system of  claim 1 , wherein the thermographic imaging system includes an infrared camera operably connected to a display screen for displaying thermographic imaging, and the thermographic imaging system includes the SCS suitability analyzer. 
     
     
         3 . The system of  claim 1 , wherein the thermographic imaging system includes an infrared camera operably connected to a display screen for displaying thermographic imaging, and the SCS suitability analyzer includes a cloud-based analyzer implemented by one or more remote processing systems, wherein the thermographic imaging system is configured to:
 capture and create digital image files for both the thermographic imaging baseline and the thermographic imaging response; and   send the digital image files to the cloud-based analyzer.   
     
     
         4 . The system of  claim 1 , wherein:
 the thermographic imaging system includes an infrared camera operably connected to a display screen for displaying thermographic imaging;   the SCS suitability analyzer includes a cloud-based SCS suitability analyzer implemented by one or more remote processing systems;   the SCS system includes a programmer and a neuromodulator configured to deliver SCS including the test SCS; and   the programmer includes a digital camera to capture thermographic imaging displayed on the display screen of the thermographic imaging system, wherein the programmer is configured to use the digital camera create digital image files for both the thermographic imaging baseline and the thermographic imaging response, and configured to send the digital image files to the cloud-based SCS suitability analyzer.   
     
     
         5 . The system of  claim 1 , wherein the thermographic imaging system includes an infrared camera operably connected to a display screen for displaying thermographic imaging, the system further comprising a digital camera to capture thermographic imaging displayed on the display screen of the thermographic imaging system, wherein the digital camera is used to capture and create digital image files for both the thermographic imaging baseline and the thermographic imaging response when displayed on the display screen, and the SCS suitability analyzer is configured to use the digital image files to compare the thermographic imaging response to the test SCS. 
     
     
         6 . A method, comprising:
 capturing a thermographic imaging baseline, using a thermal imaging system, before delivering a test spinal cord stimulation (SCS);   delivering the test SCS using an SCS system;   capturing a thermographic imaging response to the test SCS using the thermographic imaging system; and   using an SCS suitability analyzer to:
 create thermographic imaging comparison data by comparing the thermographic imaging response to the thermographic imaging baseline; 
 analyze the thermographic imaging comparison data for a perfusion response; and 
 determine if a patient is a suitable candidate for SCS based on the analyzed thermographic imaging comparison data. 
   
     
     
         7 . The method of  claim 6 , wherein:
 the SCS system includes a programmer and a neuromodulator configured to deliver SCS including the test SCS; and   the programmer of the SCS system includes the SCS suitability analyzer.   
     
     
         8 . The method of  claim 6 , wherein the thermographic imaging system includes an infrared camera operably connected to a display screen for displaying thermographic imaging, and the thermographic imaging system includes the SCS suitability analyzer. 
     
     
         9 . The method of  claim 6 , wherein the thermographic imaging system includes an infrared camera operably connected to a display screen for displaying thermographic imaging, and the SCS suitability analyzer includes a cloud-based analyzer implemented by one or more remote processing systems, wherein the method further comprises using the thermographic imaging system to:
 capture and create digital image files for both the thermographic imaging baseline and the thermographic imaging response; and   send the digital image files to the cloud-based analyzer.   
     
     
         10 . The method of  claim 6 , wherein:
 the thermographic imaging system includes an infrared camera operably connected to a display screen for displaying thermographic imaging;   the SCS suitability analyzer includes a cloud-based SCS suitability analyzer implemented by one or more remote processing systems;   the SCS system includes a programmer and a neuromodulator configured to deliver SCS including the test SCS; and
 the programmer includes a digital camera to capture thermographic imaging displayed on the display screen of the thermographic imaging system, wherein the method further includes using the programmer to create digital image files for both the thermographic imaging baseline and the thermographic imaging response and to send the digital image files to the cloud-based SCS suitability analyzer. 
   
     
     
         11 . The method of  claim 6 , wherein the thermographic imaging system includes an infrared camera operably connected to a display screen for displaying thermographic imaging, the system further comprising a digital camera to capture thermographic imaging displayed on the display screen of the thermographic imaging system, wherein the method further includes using the digital camera to capture and create digital image files for both the thermographic imaging baseline and the thermographic imaging response when displayed on the display screen, and using the digital image files to compare the thermographic imaging response to the test SCS. 
     
     
         12 . The method of  claim 11 , wherein a personal device includes the digital camera. 
     
     
         13 . The method of  claim 12 , wherein the personal device includes a phone or a tablet, and the personal device includes a downloadable app, wherein the method includes using the downloadable app to create and analyze the thermographic imaging comparison data from the digital image files, or using the downloadable app to send the digital image files to a cloud-based SCS suitability analyzer implemented by one or more remote processing systems. 
     
     
         14 . The method of  claim 6 , wherein the SCS suitability analyzer is used to create and analyze the thermographic imaging comparison data for a determined region of interest (ROI). 
     
     
         15 . The method of  claim 14 , wherein the ROI is automatically determined by automatically determining out-of-norm areas in the thermographic imaging baseline. 
     
     
         16 . The method of  claim 14 , wherein the ROI is determined using user input identifying the determined ROI, and the user input includes:
 a user selection of one or more of pre-defined regions; or   a user-defined ROI.   
     
     
         17 . The method of  claim 6 , further comprising programming neuromodulation using real-time thermographic imaging feedback. 
     
     
         18 . The method of  claim 6 , further comprising using the SCS suitability analyzer to:
 store pre-SCS thermographic data corresponding the thermographic imaging baseline and SCS-response thermographic data corresponding to the thermographic imaging response;   identify one or more pre-SCS statistical values for the pre-SCS thermographic data and one or more SCS-response statistical value(s) for the SCS-response thermographic data;   determine one or more differences between the pre-SCS thermographic data and the SCS-response thermographic data; and   compare the one or more differences to one or more threshold values to determine if the patient is suitable for SCS.   
     
     
         19 . The method of  claim 6 , further comprising using the SCS suitability analyzer to:
 store pre-SCS thermographic data corresponding the thermographic imaging baseline and SCS-response thermographic data corresponding to the thermographic imaging response;   fit the pre-SCS thermographic data to a first distribution curve and fit the SCS-response thermographic data to a second distribution curve;   identify a first set of one or more distribution parameter(s) for the first distribution curve and a second set of the one or more distribution parameters for the second distribution curve;   determine one or more differences between corresponding one or more distribution parameters in the first set and the second set; and   compare the one or more differences to one or more threshold values to determine if the patient is suitable for SCS.   
     
     
         20 . The method of  claim 19 , wherein the first distribution curve and the second distribution curves are gamma distributions, and the one or more distribution parameters include a shape parameter (k) and a scale parameter (Θ).

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